LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)

Available from:

CVS Pharmacy

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Composition:

LOPERAMIDE HYDROCHLORIDE 1 mg in 7.5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-diarrheal controls symptoms of diarrhea, including Travelers’ Diarrhea bloody or black stool taking antibiotics These may be signs of a serious condition.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE SUSPENSION
CVS PHARMACY
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CVS PHARMACY, INC. LOPERAMIDE HYDROCHLORIDE DRUG FACTS
ACTIVE INGREDIENT (IN EACH 7.5 ML)
Loperamide HCl 1 mg
PURPOS E
Anti-diarrheal
US E
controls symptoms of diarrhea, including Travelers’ Diarrhea
WARNINGS
Allergy alert: Do not use if you have ever had a rash or other
allergic reaction to loperamide HCl
DO NOT USE IF YOU HAVE
bloody or black stool
ASK A DOCTOR BEFORE USE IF YOU HAVE
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•
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking antibiotics
WHEN USING THIS PRODUCT
•
STOP USE AND ASK A DOCTOR IF
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•
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These may be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
fever
mucus in the stool
a history of liver disease
tiredness, drowsiness or dizziness may occur. Be careful when driving
or operating machinery.
symptoms get worse
diarrhea lasts for more than 2 days
you get abdominal swelling or bulging.
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away. (1-800-222-1222)
DIRECTIONS
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adults and children 12
years and over
30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each
subsequent
loose stool; but no more than 60 mL (12 tsp) in 24 hours
children 9-11 years (60-
95 lbs)
15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after
each subsequent
loose stool; but no more than 45 mL (9 tsp) in 24 hours
children 6-8 years (48-
59 lbs)
15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after
each subsequent
loose stool; but no more than 30 mL (6 tsp) in 24 hours
children under 6 years
(up to 47 lbs)
ask a doctor
OTHER INFORMATION
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INACTIVE INGREDIENTS
anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no.
10, FD&C blue no. 1, glycerin,
microcrystalline cellulose, natural and artificial mint flavor,
propylene glycol, purified water,
simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum
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